Formulation Development
Cidara Therapeutics Announces Initiation of Phase 2a Human Viral Challenge Trial to Evaluate CD388 for Universal Prevention of Influenza
Cidara Therapeutics, Inc. recently announced the initiation of its Phase 2a trial to evaluate the pre-exposure prophylactic activity of CD388 against influenza virus…..
Vaxxinity Announces First Subjects Dosed in Phase 1 Clinical Trial of UB-313 for Preventive Treatment of Migraine
Vaxxinity, Inc. recently announced the first subjects have been dosed in a Phase 1 clinical trial of UB-313, a vaccine targeting calcitonin gene-related peptide (CGRP),…
Bryn Pharma Announces Completion of its Pivotal Study Comparing UTULY Epinephrine Intranasal Spray Versus 0.3-mg Epinephrine Autoinjector for the Treatment of Anaphylaxis
Bryn Pharma LLC recently announced the completion of its pivotal study of UTULY (epinephrine nasal spray). The primary objective of the study was to evaluate whether…
Nuvectis Pharma Announces Positive Data for NXP800 in a Preclinical Model of ARID1a-Mutated Gastric Carcinoma
Nuvectis Pharma, Inc. recently announced positive data for NXP800 in a preclinical xenograft model of ARID1a-mutated gastric carcinoma. “Following the strong preclinical proof of concept…
SiSaf Announces Positive Preclinical Data for its SiS-ADO2 siRNA Program to Treat Rare Genetic Bone Disorder Osteopetrosis
SiSaf Ltd, an RNA delivery and therapeutics company, recently announce positive data confirming safety and efficacy of its Bio-Courier next-generation silicon stabilized hybrid lipid nanoparticles (sshLNP) as an….
Aptose’s New G3 Formulation of Luxeptinib Boosts Bioavailability
Aptose Biosciences Inc. recently announced the G3 formulation of luxeptinib, designed for rapid and efficient absorption, demonstrates approximately an 18-fold improvement in oral bioavailability….
Revolo Biotherapeutics Completes Enrollment in Phase 2 Trial
Revolo Biotherapeutics recently announced it has completed enrollment and has fully randomized all patients in a Phase 2a proof of concept clinical study investigating its…
Chiesi Global Rare Diseases Announces FDA Acceptance of BLA Filing for the Proposed Treatment of Alpha-Mannosidosis
Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., recently announced the US FDA has accepted the Biologics License Application (BLA) and granted…
WHITEPAPER - Launching a Drug-Device Combination: 5 Key Factors to Focus On
Going to market in a delivery device is one of the most complex steps in the life cycle of an injectable medication. A CDMO expert explains where to start and what to prepare for.
Ocuphire Pharma Announces Last Patient Completes Final Visit in ZETA-1 Phase 2b 24-Week Trial
Ocuphire Pharma, Inc. recently announced the last patient of the 103 enrolled subjects since April 2021 has completed their 24-week study visit in the Phase…
Pace Life Sciences Acquires Biopharma Global, Expanding FDA Regulatory Affairs Strategy & Consulting Capabilities to the Biotechnology & Pharmaceutical Markets
Pace Life Sciences, LLC recently announced it has acquired Biopharma Global (Biopharma). Biopharma specializes in full-service regulatory support for orphan products to treat rare diseases…
Tarsus Submits New Drug Application to the FDA for TP-03 for the Treatment of Demodex Blepharitis
Tarsus Pharmaceuticals, Inc. recently announced it has submitted a New Drug Application (NDA) to the US FDA for TP-03 (lotilaner ophthalmic solution, 0.25%) for the…
Good Therapeutics Announces Acquisition of Conditionally Active PD-1-Regulated IL-2 Program by Roche
Good Therapeutics recently announced it has entered into a definitive merger agreement to be acquired by Roche. With this acquisition, Roche will gain….
Mannkind Successfully Completes Phase 1 Study of Inhaled Clofazimine
MannKind Corporation recently announced it has successfully completed a Phase 1 study of clofazimine inhalation suspension (MNKD 101) and is planning discussions with the US…
Avalo Advances BTLA Agonist Fusion Protein to IND-Enabling Stage
Avalo Therapeutics, Inc. recently announced its human B and T Lymphocyte Attenuator (BTLA) agonist fusion protein, AVTX-008, has now entered IND-enabling studies, with a target…
Tenaya Therapeutics Announces FDA Clearance of IND & Initiation of Phase 1 Safety Study for an HDAC6 Inhibitor for Heart Failure With Preserved Ejection Fraction
Tenaya Therapeutics, Inc. recently announced clearance of its Investigational New Drug (IND) application to begin clinical testing of TN-301 by the US FDA. TN-301 is…
Synlogic Achieves Research Milestone in Collaboration With Roche for Development of Novel Synthetic Biotic to Treat Inflammatory Bowel Disease
Synlogic, Inc. recently announced it has received a milestone payment for the achievement of prespecified success criteria under the research collaboration agreement with Roche for….
Hovione Expands Drug Product Offering With New Manufacturing Line Dedicated to Continuous Tableting
Hovione recently announced it has expanded its continuous manufacturing offering and services. A new state-of-the-art continuous manufacturing facility is….
Novo Nordisk to Acquire Forma Therapeutics & Expand Presence in Sickle Cell Disease & Rare Blood Disorders
Novo Nordisk and Forma Therapeutics, Holdings Inc. recently announced they have entered into a definitive agreement under which Novo Nordisk will acquire Forma Therapeutics for….
Qureight Announces World’s First Digital Biomarker for Lung Fibrosis
For the first time, artificial intelligence (AI) using convolutional neural networks has been used to analyse trial data involving the lung disease idiopathic pulmonary fibrosis (IPF). The technology picked up….
